Speak Up: Time to Help Shape California's $12 Billion Stem Cell Future

One of the excellent features of California's $12 billion stem cell program has little to do directly with science. The feature does not deal with petri dishes, genetic manipulation or microscopes.

It has a lot to do, however, with the stem cell agency's responsiveness to the public. It involves the persons behind the test tubes and even the Big Pharma companies that are the key to bringing stem cell therapies into widespread use. 

What we are talking about is fundamental to building trust in the California Institute of Regenerative Medicine (CIRM), as the stem cell agency is officially known, and whether CIRM can sustain itself beyond the date when its money runs out again in a decade or so. 

On the surface, it's a simple matter: the ability of the public, scientists and businesses to weigh in on how CIRM spends its next $5.5 billion -- the amount that the people of California are borrowing to pay for the agency's forays. 

Next Monday represents a first-rate opportunity for the public and the myriad interested parties to show up and speak up, both to the board that governs CIRM and its top executives. Some of the matters on the table at Monday's CIRM directors' meeting are, in one form or another:

• Should CIRM spend $100 million for clinical work over the next six months and only $22 million on basic research? 
• Should it change its diversity requirements to require more awards to a more diverse group of scientists?
• Should it require wider research data sharing to improve the quality of work across the field or should it cosset CIRM-financed findings to shield intellectual property?
• How should the state spend up to $155 million to improve stem cell treatment affordability and patient access to therapies and clinical trials? Does such an effort actually represent an unnecessary subsidy to the businesses involved?

Anybody who desires to do so can participate in the CIRM board meeting, which will be online. Questions can be asked. Suggestions can be made. Complaints can be aired. 

The session represents the first big step into CIRM's new world of Proposition 14, the ballot initiative the provided the new, $5.5 billion in bond funding. The measure  also set CIRM on a wider course that offers fresh opportunities that are not without challenges.  

Deciding how to spend $5.5 billion is not a minor matter. It is tiny, however, compared to the dense processes used by another government research organization -- the 27 branches of the National Institutes of Health and their multitude of advisory bodies. In contrast, California's stem cell program is wide open, transparent and accessible to the people most affected. 

What happens beginning Monday and over the next year will fundamentally shape the success or failure of California's stem cell program, the largest such state effort in the nation and the first in California's history. 

CIRM stands open to influence -- for better or worse -- by patients, the general public, researchers and companies that have received nearly $3 billion over the last 16 years. It is now up to all those folks and more to speak up and help CIRM in its efforts to bring to market the much-heralded stem cell therapies and to be a first-rate steward of the people's money. Plus, speaking out is in the best personal and professional interests of those involved.

The agenda for Monday's meeting contains instructions for participating in the online meeting. Written comments are always useful as well as oral presentations. Written material can provide needed backup for the briefer oral comments and are directly in front of CIRM directors and staff. Comments should be emailed to kmccormack@cirm.ca.gov.

The session starts at 9 a.m. PST Monday. Don't miss an opportunity to help shape the course of California's program to cure untreatable diseases and to lead the way globally on stem cell research. 

California's New Task: A $155 Million Drive to Make Stem Cell Therapies Affordable and Accessible

The enormous cost of stem cell therapies is 
a fresh target for CIRM. 

Proposition 14, California's $5.5 billion stem cell ballot initiative, is coming home to roost, so to speak. 

Next Monday, the governing board of the state stem cell agency is scheduled to begin to settle in under the new measure, which does much more than save the agency's financial life. 

One of the agency's biggest, new challenges involves the accessibility and affordability of the staggering expense of potential stem cell therapies. On the agenda is the creation of a legally mandated "working group" to deal with the treatment cost issues. 

Details of the proposed appointments to the group and its initial steps are not yet available from the California Institute of Regenerative Medicine (CIRM), as the agency is formally known. But the 17,000-word Proposition 14 has plenty to say about the new program. Here is a rundown drawn from my new book, "California's Great Stem Cell Experiment," which deals with the first 16 years of the agency's life, policies and financial times. 

"The new playing field for CIRM encompasses particularly critical areas of costs to patients and profits for companies. Stem cell therapies are expected to be enormously expensive — $1 million or more in many cases. That’s a figure that makes health insurance companies balk and Medicare blanch.

"Proposition 14 would launch a hefty effort to make stem cell therapies more affordable and accessible. The cash behind that drive could run as high as $155 million. And that’s not necessarily going for patients.

"The intent is to create and build support for financial models for health insurance companies. CIRM would also be charged with helping to implement them. Such models would justify the cost of the theoretically one-time cures by demonstrating that they would actually save money — ending the need to treat patients in what currently seems to be an endless and expensive cycle.

"Proposition 14 speaks of covering patients and, importantly, their caregivers for medical expenses, lodging, meals and travel. That would help provide access to clinical trials that are located in prohibitively expensive urban areas, which poses financial barriers for persons who live some distance away. The added coverage would additionally help researchers and companies recruit enough trial participants, which can be a problem in some disease areas.

"The affordability panel would be permitted to operate behind closed doors as it considers the problems and weighs the solutions.

"The extraordinary cost of stem cell treatments involves something called 'reimbursement,' a biomedical industry euphemism for how companies cover the high costs of the research and still make a profit. If money is not to be made, businesses are not likely to be motivated to turn CIRM research into cures.

"Proposition 14 creates a 17-member, CIRM affordability committee to drive all this. It would work with industry and the federal government to win their support. The committee would be backed by as many as 15 CIRM staffers. The ballot allows as much as $55 million for their compensation over 10 or so years.

"But if 15 is not enough, more employees could be hired beyond the nominal cap on CIRM employees of 70 if they are compensated through the use of private cash.

"The measure additionally allows the new affordability panel to hire consultants, capping that expense at about $105 million.

"The affordability effort involves important public policy, industry and research issues that concern patient groups and industry. However, the affordability panel would be permitted to operate behind closed doors as it considers the problems and weighs the solutions.

"Votes by the committee, however, would have to be taken in public.

"Members of the panel would not be required to disclose publicly their economic or professional interests. The committee would be exempt from the state public records act except for material specifically submitted to the CIRM board."

The day-long meeting is open to the public, including scientists, who can also comment and ask questions. Comments are limited to three minutes. Lengthier comments should be emailed to the board via this address: kmccormack@cirm.ca.gov

Complete details on accessing the online meeting can be found on the agenda. 

(See here for a discussion of the $182 million awards program scheduled to be approved on Monday for the first six months of the next year.)

No. 1 Read: A 'Deep Dive' Into the Sweeping Changes Made in California's $12 Billion Stem Cell Program

Capitol Weekly's Twitter item on its most
read story of 2020

Capitol Weekly, the respected online news service devoted to state government and politics, this week reported that its most-read story of the year is an article headlined "Proposition 14: There’s much, much more than meets the eye."

The piece was written by yours truly and dealt with the successful ballot initiative that saved the state stem cell agency from financial oblivion with a $5.5 billion infusion of borrowed money. 

The 17,000-word measure, however, also involved a sweeping expansion of the scope of the agency and made a host of consequential changes. The freelance piece began: 

"Proposition 14, the fall ballot measure to save California’s stem cell agency from financial extinction, contains much, much more than the $5.5 billion that it is seeking from the state’s voters.

"Added to the agency’s charter would be research involving mental health, 'therapy delivery,' personalized medicine and 'aging as a pathology.' That is not to mention a greater emphasis on supporting 'vital research opportunities' that are not stem cell-related.

"The measure would enlarge the board from 29 to 35 members. Even at 29, the board has been much criticized for its large size, which creates more possibilities for conflicts of interest, a long-standing issue for the agency.

"Proposition 14 would ban royalties generated by state-backed stem cell inventions from being used for such things as prisons and schools, isolating the funds from tinkering by lawmakers."

The Aug. 31 article was drawn from my new book, "California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures."  The book is a product of 15 years of coverage of the stem cell agency and posting of more than 5,000 items on its activities on the California Stem Cell Report.

Other stories in Capitol Weekly's top ten, most-read articles include the governor's plans for a stricter Covid lockdown, the tough sell facing California ballot measures and Capitol Weekly's list of the state's 100, top unelected political power players.

Capitol Weekly has been around for decades, originally as a print publication. It is now part of Open California, a nonprofit that helps to fill a gap left by diminishing coverage of state issues by the mainstream media. 

On its website, Open California says, 

"Our mission is to inform, enlighten and educate Californians about public policy and state governance, and to provide a platform for engagement with public officials, advocates and political interests.  To meet this goal, Open California publishes continuing, in-depth, nonpartisan coverage of current policy and political issues, and hosts regular forums for public discussion of policy and California politics."

Need Work? California's Stem Cell Agency Looking to Hire Ten

Looking for a job with an exciting and unique $12 billion stem cell research funding organization in the Golden State of California.?

The state stem cell agency, which is now into everything from "aging as a pathology" to mental health, is looking to hire 10 persons to fill posts ranging vice president of science to administrative assistant.

While the positions are yet to be officially posted online, here is the list of expected openings, according to the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is officially known. 

(Update: On Jan. 2, applications for seven of these positions were available on the CIRM web site.)

• Senior Executive Assistant
• Senior Science Officer, Review
• Project Manager, Review
• Vice President of Science
• General Counsel
• Grants Management Specialist
• Administrative Assistant
• Director of Finance
• Business Services Officer
• Senior Science Officer

Here is a link to the pay schedule at CIRM. Here is a link to a document dealing with the agency's compensation program as of today.

Official postings for the positions could come as early as late this month. They will appear on this CIRM web page.

CIRM currently has 33 employees. Proposition 14 contains a nominal cap of 70 but also permits the number to grow substantially if the employees are compensated through cash that is not part of the agency's official state bond funding. 

CIRM is currently based in Oakland, Ca. 

California Stem Cell Agency Set to Fund $182 Million in Research in Next Six Months

Click on the above to see a recording of today's online meeting of the CIRM Science Committee

California's newly rejuvenated stem cell program today kicked off its fresh spending plans with a $182 million effort that focuses heavily on awards that could lead more quickly to actual treatments.

The plan was approved by the Science Committee of the governing board of the California Institute for Regenerative Medicine (CIRM), as the $12 billion agency is formally known. CIRM was running out of money until voters this fall approved Proposition 14 and rescued the agency from financial oblivion. 

The $182 million plan for the first half of next year represents CIRM's first major dip into its new, $5.5 billion bucket that was created by narrow voter approval of Proposition 14. The full board is expected to approve the new research budget at its Dec. 21 meeting. 

The program allots $100 million for possibly 10 clinical awards in the next six months. Translational research will receive $60 million (11 awards). "Quest" research is allotted $22 million for 15 awards. Quest awards involve early stage, basic research while translational research involves attempts to move basic research into the clinical level. 

Clinical trials are the last hurdle to clear before a treatment can be approved by the federal government for widespread use. No CIRM-financed stem cell treatments have yet received that approval since the agency began its work 16 years ago. CIRM, however, has helped to fund 68 ongoing clinical trials. 

The Science Committee has 10 members, at least six of whom are linked to institutions or businesses that could apply for CIRM funding.  While members of the 35-member CIRM board can vote on the overall research budget and also "concept" plans for such things as Quest and clinical research, they are barred from voting on specific applications from institutions that they are connected to.  

The Science Committee also approved changes aimed at increasing diversity in CIRM-related research and requiring greater data sharing by scientists. The committee strengthened the staff-proposed diversity language by also proposing scoring applications on how they beef up diversity among researchers. Details on that are yet to be worked out and will be presented to the full board on Dec. 21. 

A call for more diversity among researchers was aired last month at a meeting of the only state entity charged with reviewing CIRM's financial affairs. 

The data-sharing requirement triggered some concern about whether it would be a disincentive to some researchers who feared losing control over their intellectual property.  However, CIRM CEO Maria Millan said the agency was treading carefully to take those concerns into consideration. 

Researchers will be able to apply for the awards shortly after Jan. 1 when detailed program announcements will be released by CIRM. 

Here are links to the changes approved for the Quest program, the translational program and the clinical programs.